Iahn Cajigas
The purpose of this trial is to study the safety, practicality, and effectiveness of deep brain stimulation (DBS) therapy in a brain region called the cuneiform nucleus (CnF) to treat disabling freezing of gait (FOG) in patients with Parkinson's disease (PD) when standard treatments are no longer effective. The study uses either the Medtronic's Percept™ PC or RC systems for DBS therapy. Please note that although the Medtronic systems are FDA-approved for other diseases, they have not been approved for the treatment of FOG in PD and their use for stimulation of the CnF target is experimental.
This is a multi-site, prospective, randomized, sham-controlled, crossover, double-blinded feasibility clinical trial assessing the extent to which cuneiform nucleus deep brain stimulation (CnF DBS) can ameliorate freezing of gait (FOG) in Parkinson's Disease (PD) patients with severe, Levodopa-resistant gait freezing. The study intends to determine the optimal stimulation parameters (frequency, pulse, amplitude) that maximize gait performance while minimizing any potential side effects and to evaluate the effect of CnF DBS on other PD symptoms (including pain) and quality of life. Participati…
Inclusion Criteria: 1. Age between 35 and 80 years 2. Confirmed diagnosis of PD, according to a movement disorder neurologist, with documented exclusion of other disorders such as Frontotemporal Dementia (FTD), frontal gait disorder, Normal Pressure Hydrocephalus (NPH), or Progressive Supranuclear Palsy (PSP) 3. Postural Instability and Gait Difficulty (PIGD)-predominant PD, defined by a Tremor-Dominant (TD)/PIGD ratio of ≤ 0.90, as calculated from MDS-UPDRS items, according to previously validated methods46 4. FOGQ score of \> 12, consistent with severe gait disorder47-49 5. Clinical observa…
Active CnF DBS will be delivered using predefined stimulation parameter ranges considered potentially therapeutic based on prior preclinical and clinical data.
Control (sham or sub-therapeutic) stimulation will consist of stimulation settings expected to have no or minimal physiological effect (e.g., stimulation off or amplitude below a predefined threshold).
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